First-Ever Point-Of-Care COVID-19 Serology Test Granted EUA By FDA

The US agency on 23 September granted emergency use authorization for the Assure COVID-19 IgG/IgM Rapid Test Device to be used in point-of-care settings like doctor’s offices, hospitals, urgent care centers and emergency rooms. The test requires a fingerstick to draw blood.

Health Screenings: Fingerstick or Venous Blood Draw for Laboratory Hematology
The Assure POC test requires a fingerstick to draw blood

The US Food and Drug Administration on 23 September granted emergency use authorization (EUA) to Assure Tech Co. Ltd. for its point-of-care serology test for COVID-19. It’s the first POC blood test for determining whether a person has been exposed to the SARS-CoV-2 virus.

The Assure COVID-19 IgG/IgM Rapid Test Device – originally issued an EUA in July for use only in labs – requires a fingerstick to draw blood. With the fresh EUA,...

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